MAUDE Adverse Event Report: ICU MEDICAL ,TRANSPAC® IV MONITORING KIT W/ SAFESET RESERVOIR

Model Number	46103-68
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: no lot number supplied for review.The database was reviewed and there was one other complaint found but it was never returned for investigation.Visual inspection: 7/10/2017 received one (1) used 46103-68, transpac® iv monitoring kit w/ safeset reservoir, 24" tubing,03 ml intraflo® flush and needleless valve; lot# unknown.The as received 46103-68 unit, blood was found in safeset reservoir, 3" arterial pressure tubing f/m, stopcock, 4-way, luer valve swabable and another 3" arterial pressure tubing.The 60" admin iv set w/ macro and conn, if 1 port 3ml, transpac iv, stopcock cap cover subassembly, female luer bonded to 10.5" tubing were primed.During the decontamination process it was able to draw blood from marvels valve using 10ml bd syringe and also was able to push safeset plunger forward with minimum force.Functional testing: the 3" pressure tubing was removed from the stopcock.The 4-way stopcock was flushed with the decontamination solution several times and blood clots were removed.Also blood clots were removed from the 3" arterial pressure tubing.Once the clots were removed the 46103-68 then easily primed with water at gravity pressure (1.5psig).The safest syringe was also easily primed with water and then the fluid aspirated through the set without any difficulty or issues.The set was then leak tested at 9psig for 30 seconds.No leaks were observed.A 10 cc syringe filled with water was attached to the luer activated valve (marvelous) and water was flushed and aspirated through the stopcock and the 3" pressure tubing with no issues.The safeset syringe also locked with no issues.The luer activated valve (marvelous) was checked for leaks no leakage or spraying of water through the valve occurred.Final analysis summary: the reported product problem for unable to flush the lines was confirmed.The problem does appear to be due to the blood clots formed at the stopcock with the luer activated valve (marvelous) and the 3" pressure tubing stopcock connection blocking (occluding the fluid path) and thus can create high pressures with use of the safeset syringe.Once the set was decontaminated and the blood clots were cleared and removed the set primed and flushed with no issues found.The safeset syringe also easily flushed with no issues and was able to lock.The set met the leak testing requirements of the specification and so did the luer activated valve (marvelous) on the stopcock.The valve only sprayed water when tested above the specification.There were no issues found with the set once the blood clots were removed.Icu medical will monitor and trend.
Event or Problem Description
During the blood sampling process blood spurted from the luer activated sampling port while attempting to return blood to the patient.The nurse could not flush the line despite all stopcock handles in the correct position.The safeset plunger handle was stuck in the "open" position and could not be pushed forwarded to lock.No adverse patient consequences reported.

• Brand Name: ,TRANSPAC® IV MONITORING KIT W/ SAFESET RESERVOIR
• Common Device Name: TRANSPAC® IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84123
• MDR Report Key: 6712120
• Report Number: 2025816-2017-00154
• Device Sequence Number: 16647573
• Product Code: DRS
• UDI-Device Identifier: 00887709050723
• UDI-Public: 887709050723
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 46103-68
• Device Catalogue Number: 46103-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1